Patient leaflet - TROSEMPT XL 60 MG PROLONGED-RELEASE CAPSULE HARD, KENPORURIN XL 60 MG PROLONGED-RELEASE CAPSULE HARD, REGURIN XL 60 MG PROLONGED-RELEASE CAPSULE HARD
Regurin® XL 60mg prolonged-release capsules, hard (trospium chloride)
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
- The name of this medicine is Regurin XL 60mg prolonged-release capsules, hard but will be referred to as Regurin XL throughout the remainder of this leaflet.
-
1) What Regurin XL is and what it is used for
-
2) What do you need to know before you take Regurin XL
-
3) How to take Regurin XL
-
4) Possible side effects
-
5) How to store Regurin XL
-
6) Contents of the pack and other information
1) what regurin xl is and what it is used for
Regurin XL is a medicine used for the relaxation of the muscles of the urinary bladder. It is used for the treatment of symptoms associated with involuntary loss of urine (wetting) and/or increased frequency of urination and/or urgency of urination in patients with an overactive urinary bladder.
-
2) WHAT DO YOU NEED TO KNOW BEFORE YOU TAKE REGURIN XL
Do not take Regurin XL
-
– If you have ever had an allergic reaction to trospium chloride or any of the other ingredients of this medicine (listed in section 6). (An allergic reaction can be a rash, itchiness or shortness of breath.).
-
– If you suffer from any of the following:
- urinary retention, i.e. blockage of the urinary tract,
- the eye condition narrow-angle glaucoma,
- abnormal/faster than normal heart beats,
- myasthenia gravis (a disorder that causes muscle fatigue),
- a severe gastro-intestinal condition, such as toxic megacolon,
- problems with your kidneys,
- severe problems with your liver.
Warnings and precautions
Talk to your doctor or pharmacist before taking Regurin XL if you suffer from any of the following:
- any type of stomach or bowel obstruction,
- an impaired urine flow (e.g. in the case of benign tissue growth of the male prostate),
- neuropathy, i.e. nerve damage,
- a hiatus hernia associated with reflux oesophagitis. This is usually associated with heartburn which worsens on bending or lying down,
- an overactive thyroid,
- any heart conditions, such as coronary artery disease or congestive heart failure,
- any liver problems.
Patients with liver disorders
You should talk to your doctor if you have a liver disorder. Patients with severe liver disorders should not take this medicine.
Patients with kidney disorders
You should talk to your doctor if you have a kidney disorder. Patients with kidney disorders should not take this medicine.
Children under the age of 18 years
Do NOT give Regurin XL to children under 18 years of age.
Other medicines and Regurin XL
Please tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.
Inform your doctor in particular if you are taking any of the following medicines:
-
– certain anti-depressants e.g. amitriptyline or imipramine
-
– some medicines for the treatment of asthma that may accelerate the heart rate (e.g. salbutamol)
-
– other medicines with anticholinergic action (e.g. amantadine – used to treat Parkinson’s disease)
-
– metoclopramide – medicine used for nausea and vomiting
-
– medicines containing guar, colestipol or colestyramine.
Please note that this information may also apply to medicines that you have used recently.
Pregnancy and breast-feeding and fertility
Since there is no experience with trospium chloride during pregnancy and breast-feeding, Regurin XL should be taken during pregnancy and breast-feeding only if your doctor considers it absolutely necessary.
Driving and using machines
Even when used as directed, this medicine can affect vision so that the ability to actively participate in road traffic, operate machines or work may be impaired. Therefore, do not drive motor vehicles, operate machines or perform other hazardous activities if you are suffering from blurred vision.
Regurin XL contains sucrose and sodium
If you have been told by your doctor that you have an intolerance to some sugars, such as sucrose, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol sodium (23mg) per capsule, that is to say it is essentially ‘sodium-free’.
3) how to take regurin xl
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Usual dose unless otherwise prescribed by your doctor
Unless otherwise prescribed by your doctor, the usual daily dose is one Regurin XL prolonged-release capsule.
Method of administration
Swallow one prolonged-release capsule whole with a glass of water.
Take the capsule at least one hour before meal on an empty stomach.
Duration of administration
Your doctor will determine the duration of treatment.
The need for continued treatment should be checked at regular intervals of 3 – 6 months.
Patients with a kidney disorder should consult their doctor and not take this medicine.
Patients with a liver disorder should consult their doctor before taking this medicine.
If you take more Regurin XL than you should
No symptoms and signs of intoxication in humans have been reported to date.
If you have taken too much Regurin XL you should inform immediately a doctor or pharmacist who will decide on further measures.
If you forget to take Regurin XL
Do not take a double dose to make up for a forgotten dose. Continue with the regular intake as described in the dosage directions.
If you stop taking Regurin XL
Your symptoms may return if you stop taking Regurin XL before recommended by your doctor. Therefore, you should take Regurin XL for as long as prescribed by your doctor. Please consult your doctor if you wish to stop treatment.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4) possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported for Regurin XL in clinical trials:
Very common side effects, affects more than 1 user in 10
- dryness of the mouth.
- constipation, nausea, abdominal pain, indigestion,
- dry eyes, dry nose.
- flatulence.
- difficulty emptying the bladder, urinary retention,
- fast heart rate, palpitations,
- difficulty seeing objects close-up,
- rash,
- general feeling of weakness.
- urinary tract infection,
- headache.
Other possible side effects, for which the frequency is not known
- sporadic cases of hallucination, confusion and agitation have occurred mostly in elderly patients and can be facilitated by neurological diseases and/or other drugs, with a similar mechanism of action taken at the same time.
The following side effects have also been reported for trospium (trospium is the active ingredient of Regurin XL; it is not known if these side effects will also occur with the capsules that you have been prescribed):
Difficulty in breathing, diarrhoea, chest pain, slight to moderate increase of certain liver values (serum transaminases), fast irregular heartbeat, joint or muscle pains, dizziness.
The following “very rare” side effects below are important and will require immediate action if you experience them. You should stop taking Regurin XL and see your doctor immediately if the following symptoms occur:
- swelling of the face, tongue and windpipe which can cause great difficulty in breathing,
- a sudden allergic reaction with shortness of breath, rash, wheezing and drop of blood pressure.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5) how to store regurin xl
- Keep out of the sight and reach of children.
- Do not use Regurin XL after the expiry date which is stated on the label and the carton after EXP. The expiry date refers to the last day of that month.
- This medicinal product does not require any special storage conditions.
- If your capsules become discoloured or show any sign of deterioration, return them to your pharmacist.
- Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6) contents of the pack and other information
What Regurin XL contains
The active substance is: Trospium chloride.
Each prolonged-release capsule contains 60mg trospium chloride.
The other ingredients are: sucrose, maize starch, methyl acrylate-methyl methacrylate-methacrylic acid-copolymer, sodium dodecyl sulphate, ammonium hydroxide, medium chain triglycerides, oleic acid, ethylcellulose, titanium dioxide (E171), hypromellose, macrogol 400, polysorbate 80, triethyl citrate, talc, gelatin, yellow iron oxide (E172), red iron oxide (E172), shellac and propylene glycol.
See section 2 ‘Regurin XL contains sucrose and sodium’.
What Regurin XL looks like and contents of the pack
Regurin XL 60mg prolonged-release capsules, hard consist of an opaque orange cap and an opaque white body imprinted with “SAN 60” and containing white to off-white pellets.
Regurin XL is available in bottle packs containing 30 or 100 capsules or blister packs containing 30 capsules.
Manufactured by
Madaus GmbH, 51101 Cologne, Germany.
Procured from within the EU by Product Licence Holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5–7 Tintagel Way, Aldridge, Walsall, WS9 8ER. UK
Repackaged by MPT Pharma Ltd.
PL: 33532/0437
Leaflet dated 15th December 2021
Leaflet coded XXXXXXXXXX
Regurin® is a registered trademark of MADAUS GmbH.
To request a copy of this leaflet in Braille, large print or audio please call 01922 745645 and ask for the Regulatory Department.
Kenporurin XL 60mg prolonged-release capsules, hard (trospium chloride)
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
- The name of this medicine is Kenporurin XL 60mg prolonged-release capsules, hard but will be referred to as Kenporurin XL throughout the remainder of this leaflet.
-
1) What Kenporurin XL is and what it is used for
-
2) What do you need to know before you take Kenporurin XL
-
3) How to take Kenporurin XL
-
4) Possible side effects
-
5) How to store Kenporurin XL
-
6) Contents of the pack and other information
1) what kenporurin xl is and what it is used for
Kenporurin XL is a medicine used for the relaxation of the muscles of the urinary bladder. It is used for the treatment of symptoms associated with involuntary loss of urine (wetting) and/or increased frequency of urination and/or urgency of urination in patients with an overactive urinary bladder.
-
2) WHAT DO YOU NEED TO KNOW BEFORE YOU TAKE KENPORURIN XL
Do not take Kenporurin XL
-
– If you have ever had an allergic reaction to trospium chloride or any of the other ingredients of this medicine (listed in section 6). (An allergic reaction can be a rash, itchiness or shortness of breath.).
-
– If you suffer from any of the following:
- urinary retention, i.e. blockage of the urinary tract,
- the eye condition narrow-angle glaucoma,
- abnormal/faster than normal heart beats,
- myasthenia gravis (a disorder that causes muscle fatigue),
- a severe gastro-intestinal condition, such as toxic megacolon,
- problems with your kidneys,
- severe problems with your liver.
Warnings and precautions
Talk to your doctor or pharmacist before taking Kenporurin XL if you suffer from any of the following:
- any type of stomach or bowel obstruction,
- an impaired urine flow (e.g. in the case of benign tissue growth of the male prostate),
- neuropathy, i.e. nerve damage,
- a hiatus hernia associated with reflux oesophagitis. This is usually associated with heartburn which worsens on bending or lying down,
- an overactive thyroid,
- any heart conditions, such as coronary artery disease or congestive heart failure,
- any liver problems.
Patients with liver disorders
You should talk to your doctor if you have a liver disorder. Patients with severe liver disorders should not take this medicine.
Patients with kidney disorders
You should talk to your doctor if you have a kidney disorder. Patients with kidney disorders should not take this medicine.
Children under the age of 18 years
Do NOT give Kenporurin XL to children under 18 years of age.
Other medicines and Kenporurin XL
Please tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.
Inform your doctor in particular if you are taking any of the following medicines:
-
– certain anti-depressants e.g. amitriptyline or imipramine
-
– some medicines for the treatment of asthma that may accelerate the heart rate (e.g. salbutamol)
-
– other medicines with anticholinergic action (e.g. amantadine – used to treat Parkinson’s disease)
-
– metoclopramide – medicine used for nausea and vomiting
-
– medicines containing guar, colestipol or colestyramine.
Please note that this information may also apply to medicines that you have used recently.
Pregnancy and breast-feeding and fertility
Since there is no experience with trospium chloride during pregnancy and breast-feeding, Kenporurin XL should be taken during pregnancy and breast-feeding only if your doctor considers it absolutely necessary.
Driving and using machines
Even when used as directed, this medicine can affect vision so that the ability to actively participate in road traffic, operate machines or work may be impaired. Therefore, do not drive motor vehicles, operate machines or perform other hazardous activities if you are suffering from blurred vision.
Kenporurin XL contains sucrose and sodium
If you have been told by your doctor that you have an intolerance to some sugars, such as sucrose, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol sodium (23mg) per capsule, that is to say it is essentially ‘sodium-free’.
3) how to take kenporurin xl
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Usual dose unless otherwise prescribed by your doctor
Unless otherwise prescribed by your doctor, the usual daily dose is one Kenporurin XL prolonged-release capsule.
Method of administration
Swallow one prolonged-release capsule whole with a glass of water.
Take the capsule at least one hour before meal on an empty stomach.
Duration of administration
Your doctor will determine the duration of treatment.
The need for continued treatment should be checked at regular intervals of 3 – 6 months.
Patients with a kidney disorder should consult their doctor and not take this medicine.
Patients with a liver disorder should consult their doctor before taking this medicine.
If you take more Kenporurin XL than you should
No symptoms and signs of intoxication in humans have been reported to date.
If you have taken too much Kenporurin XL you should inform immediately a doctor or pharmacist who will decide on further measures.
If you forget to take Kenporurin XL
Do not take a double dose to make up for a forgotten dose. Continue with the regular intake as described in the dosage directions.
If you stop taking Kenporurin XL
Your symptoms may return if you stop taking Kenporurin XL before recommended by your doctor. Therefore, you should take Kenporurin XL for as long as prescribed by your doctor. Please consult your doctor if you wish to stop treatment.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4) possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported for Kenporurin XL in clinical trials:
Very common side effects, affects more than 1 user in 10
- dryness of the mouth.
- constipation, nausea, abdominal pain, indigestion,
- dry eyes, dry nose.
- flatulence.
- difficulty emptying the bladder, urinary retention,
- fast heart rate, palpitations,
- difficulty seeing objects close-up,
- rash,
- general feeling of weakness.
- urinary tract infection,
- headache.
Other possible side effects, for which the frequency is not known
- sporadic cases of hallucination, confusion and agitation have occurred mostly in elderly patients and can be facilitated by neurological diseases and/or other drugs, with a similar mechanism of action taken at the same time.
The following side effects have also been reported for trospium (trospium is the active ingredient of Kenporurin XL; it is not known if these side effects will also occur with the capsules that you have been prescribed):
Difficulty in breathing, diarrhoea, chest pain, slight to moderate increase of certain liver values (serum transaminases), fast irregular heartbeat, joint or muscle pains, dizziness.
The following “very rare” side effects below are important and will require immediate action if you experience them. You should stop taking Kenporurin XL and see your doctor immediately if the following symptoms occur:
- swelling of the face, tongue and windpipe which can cause great difficulty in breathing,
- a sudden allergic reaction with shortness of breath, rash, wheezing and drop of blood pressure.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5) how to store kenporurin xl
- Keep out of the sight and reach of children.
- Do not use Kenporurin XL after the expiry date which is stated on the label and the carton after EXP. The expiry date refers to the last day of that month.
- This medicinal product does not require any special storage conditions.
- If your capsules become discoloured or show any sign of deterioration, return them to your pharmacist.
- Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6) contents of the pack and other information
What Kenporurin XL contains
The active substance is: Trospium chloride.
Each prolonged-release capsule contains 60mg trospium chloride.
The other ingredients are: sucrose, maize starch, methyl acrylate-methyl methacrylate-methacrylic acid-copolymer, sodium dodecyl sulphate, ammonium hydroxide, medium chain triglycerides, oleic acid, ethylcellulose, titanium dioxide (E171), hypromellose, macrogol 400, polysorbate 80, triethyl citrate, talc, gelatin, yellow iron oxide (E172), red iron oxide (E172), shellac and propylene glycol.
See section 2 ‘Kenporurin XL contains sucrose and sodium’.
What Kenporurin XL looks like and contents of the pack
Kenporurin XL 60mg prolonged-release capsules, hard consist of an opaque orange cap and an opaque white body imprinted with “SAN 60” and containing white to off-white pellets.
Kenporurin XL is available in bottle packs containing 30 or 100 capsules or blister packs containing 30 capsules.
Manufactured by
Madaus GmbH, 51101 Cologne, Germany.
Procured from within the EU by Product Licence Holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5–7 Tintagel Way, Aldridge, Walsall, WS9 8ER. UK
Repackaged by MPT Pharma Ltd.
PL: 33532/0437
Leaflet dated 15th December 2021
Leaflet coded XXXXXXXXXX
| POM |
To request a copy of this leaflet in Braille, large print or audio please call 01922 745645 and ask for the Regulatory Department.
Trosempt XL 60mg prolonged-release capsules, hard (trospium chloride)
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
- The name of this medicine is Trosempt XL 60mg prolonged-release capsules, hard but will be referred to as Trosempt XL throughout the remainder of this leaflet.
-
1) What Trosempt XL is and what it is used for
-
2) What do you need to know before you take Trosempt XL
-
3) How to take Trosempt XL
-
4) Possible side effects
-
5) How to store Trosempt XL
-
6) Contents of the pack and other information
1) what trosempt xl is and what it is used for
Trosempt XL is a medicine used for the relaxation of the muscles of the urinary bladder. It is used for the treatment of symptoms associated with involuntary loss of urine (wetting) and/or increased frequency of urination and/or urgency of urination in patients with an overactive urinary bladder.
-
2) WHAT DO YOU NEED TO KNOW BEFORE YOU TAKE TROSEMPT XL
Do not take Trosempt XL
-
– If you have ever had an allergic reaction to trospium chloride or any of the other ingredients of this medicine (listed in section 6). (An allergic reaction can be a rash, itchiness or shortness of breath.).
-
– If you suffer from any of the following:
- urinary retention, i.e. blockage of the urinary tract,
- the eye condition narrow-angle glaucoma,
- abnormal/faster than normal heart beats,
- myasthenia gravis (a disorder that causes muscle fatigue),
- a severe gastro-intestinal condition, such as toxic megacolon,
- problems with your kidneys,
- severe problems with your liver.
Warnings and precautions
Talk to your doctor or pharmacist before taking Trosempt XL if you suffer from any of the following:
- any type of stomach or bowel obstruction,
- an impaired urine flow (e.g. in the case of benign tissue growth of the male prostate),
- neuropathy, i.e. nerve damage,
- a hiatus hernia associated with reflux oesophagitis. This is usually associated with heartburn which worsens on bending or lying down,
- an overactive thyroid,
- any heart conditions, such as coronary artery disease or congestive heart failure,
- any liver problems.
Patients with liver disorders
You should talk to your doctor if you have a liver disorder. Patients with severe liver disorders should not take this medicine.
Patients with kidney disorders
You should talk to your doctor if you have a kidney disorder. Patients with kidney disorders should not take this medicine.
Children under the age of 18 years
Do NOT give Trosempt XL to children under 18 years of age.
Other medicines and Trosempt XL
Please tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.
Inform your doctor in particular if you are taking any of the following medicines:
-
– certain anti-depressants e.g. amitriptyline or imipramine
-
– some medicines for the treatment of asthma that may accelerate the heart rate (e.g. salbutamol)
-
– other medicines with anticholinergic action (e.g. amantadine – used to treat Parkinson’s disease)
-
– metoclopramide – medicine used for nausea and vomiting
-
– medicines containing guar, colestipol or colestyramine.
Please note that this information may also apply to medicines that you have used recently.
Pregnancy and breast-feeding and fertility
Since there is no experience with trospium chloride during pregnancy and breast-feeding, Trosempt XL should be taken during pregnancy and breast-feeding only if your doctor considers it absolutely necessary.
Driving and using machines
Even when used as directed, this medicine can affect vision so that the ability to actively participate in road traffic, operate machines or work may be impaired. Therefore, do not drive motor vehicles, operate machines or perform other hazardous activities if you are suffering from blurred vision.
Trosempt XL contains sucrose and sodium
If you have been told by your doctor that you have an intolerance to some sugars, such as sucrose, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol sodium (23mg) per capsule, that is to say it is essentially ‘sodium-free’.
3) how to take trosempt xl
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Usual dose unless otherwise prescribed by your doctor
Unless otherwise prescribed by your doctor, the usual daily dose is one
Trosempt XL prolonged-release capsule.
Method of administration
Swallow one prolonged-release capsule whole with a glass of water.
Take the capsule at least one hour before meal on an empty stomach.
Duration of administration
Your doctor will determine the duration of treatment.
The need for continued treatment should be checked at regular intervals of 3 – 6 months.
Patients with a kidney disorder should consult their doctor and not take this medicine.
Patients with a liver disorder should consult their doctor before taking this medicine.
If you take more Trosempt XL than you should
No symptoms and signs of intoxication in humans have been reported to date.
If you have taken too much Trosempt XL you should inform immediately a doctor or pharmacist who will decide on further measures.
If you forget to take Trosempt XL
Do not take a double dose to make up for a forgotten dose. Continue with the regular intake as described in the dosage directions.
If you stop taking Trosempt XL
Your symptoms may return if you stop taking Trosempt XL before recommended by your doctor. Therefore, you should take Trosempt XL for as long as prescribed by your doctor. Please consult your doctor if you wish to stop treatment.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4) possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported for Trosempt XL in clinical trials:
Very common side effects, affects more than 1 user in 10
- dryness of the mouth.
- constipation, nausea, abdominal pain, indigestion,
- dry eyes, dry nose.
- flatulence.
- difficulty emptying the bladder, urinary retention,
- fast heart rate, palpitations,
- difficulty seeing objects close-up,
- rash,
- general feeling of weakness.
- urinary tract infection,
- headache.
Other possible side effects, for which the frequency is not known
- sporadic cases of hallucination, confusion and agitation have occurred mostly in elderly patients and can be facilitated by neurological diseases and/or other drugs, with a similar mechanism of action taken at the same time.
The following side effects have also been reported for trospium (trospium is the active ingredient of Trosempt XL; it is not known if these side effects will also occur with the capsules that you have been prescribed):
Difficulty in breathing, diarrhoea, chest pain, slight to moderate increase of certain liver values (serum transaminases), fast irregular heartbeat, joint or muscle pains, dizziness.
The following “very rare” side effects below are important and will require immediate action if you experience them. You should stop taking Trosempt XL and see your doctor immediately if the following symptoms occur:
- swelling of the face, tongue and windpipe which can cause great difficulty in breathing,
- a sudden allergic reaction with shortness of breath, rash, wheezing and drop of blood pressure.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5) how to store trosempt xl
- Keep out of the sight and reach of children.
- Do not use Trosempt XL after the expiry date which is stated on the label and the carton after EXP. The expiry date refers to the last day of that month.
- This medicinal product does not require any special storage conditions.
- If your capsules become discoloured or show any sign of deterioration, return them to your pharmacist.
- Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6) contents of the pack and other information
What Trosempt XL contains
The active substance is: Trospium chloride.
Each prolonged-release capsule contains 60mg trospium chloride.
The other ingredients are: sucrose, maize starch, methyl acrylate-methyl methacrylate-methacrylic acid-copolymer, sodium dodecyl sulphate, ammonium hydroxide, medium chain triglycerides, oleic acid, ethylcellulose, titanium dioxide (E171), hypromellose, macrogol 400, polysorbate 80, triethyl citrate, talc, gelatin, yellow iron oxide (E172), red iron oxide (E172), shellac and propylene glycol.
See section 2 ‘Trosempt XL contains sucrose and sodium’.
What Trosempt XL looks like and contents of the pack
Trosempt XL 60mg prolonged-release capsules, hard consist of an opaque orange cap and an opaque white body imprinted with “SAN 60” and containing white to off-white pellets.
Trosempt XL is available in bottle packs containing 30 or 100 capsules or blister packs containing 30 capsules.
Manufactured by
Madaus GmbH, 51101 Cologne, Germany.
Procured from within the EU by Product Licence Holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5–7 Tintagel Way, Aldridge, Walsall, WS9 8ER. UK
Repackaged by MPT Pharma Ltd.
PL: 33532/0437
Leaflet dated 15th December 2021
Leaflet coded XXXXXXXXXX
To request a copy of this leaflet in Braille, large print or audio please call 01922 745645 and ask for the Regulatory Department.